- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Eisai, Inc (Nutley, NJ)
- …also consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is ... your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets...broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Merck & Co. (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues Demonstration of computer… more
- GRAIL (Trenton, NJ)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Sumitomo Pharma (Trenton, NJ)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more
- Taiho Oncology (Princeton, NJ)
- …and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or status ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... (no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND →… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
